Module 0 · Domain Map

A new drug has just been approved. Now what?

A company spends a decade and billions developing a new drug. A regulator — the EMA in Europe, the FDA in the US — reviews the evidence and says: yes, this is safe enough, and it works. The drug can now be sold.

So here's the real question: should your country's health system actually pay for it?

If a regulator has approved a drug, should the health system automatically fund it?

'Approved' means only one thing: allowed to be sold. It says nothing about whether the drug is worth buying — for whom, instead of what, and at what cost to everything else your system could fund. Answering that question is what this entire course is about.

The one big question

Every health system lives with the same hard fact: there is never enough money for everything. A fixed budget means every pound spent on one treatment is a pound not spent on another.

So the question is never simply "Is this drug good?" It's:

Is this drug worth paying for — more worth it than the other things we could do with the same money?

That single decision is too big to answer in one go. So we break it into three smaller questions. The rest of this course is built around them.

  1. Does it actually work?
  2. How sure can we be?
  3. Is it worth the cost?

Which question is this?

Here's the surprising part: you can already tell these three apart — on instinct alone. Let's prove it. For each statement, tap the question it belongs to.

Putting it together

Notice what just happened. Almost every real debate in HTA is one of these three questions in disguise — or all three at once.

And they stack. They feed a single decision.

Does it work?
How sure are we?
Is it worth it?
Should we pay for it — and on what terms?

The catch is that the answers don't substitute for each other:

HTA is the discipline of holding all three in view at once — and being honest about the trade-offs.

And here's the quiet reason the third question even exists: opportunity cost. Money has alternative uses. Fund this, and something else goes unfunded — often invisibly. Good HTA never forgets the patients you never see: the ones whose care was quietly crowded out.

Three disciplines

Each of these questions is owned by a different field. HTA is where they meet:

Does it work?medicine & clinical science
How sure are we?statistics & epidemiology
Is it worth it?health economics

That's what makes HTA both awkward and powerful: almost nobody is trained in all three at once. By the end of this course, you will be fluent in all of them.

You are here

Here's the journey ahead — same three questions, in order.

① Why any of this exists M1

The decision problem, opportunity cost, who's in the room, and why "approved" never means "funded."

② Does it work? How sure are we? — the evidence M2–M4

Reading studies, telling signal from noise, and pulling all the evidence together into one verdict.

③ Is it worth it? — the economics M5–M10

Measuring health itself, weighing benefit against cost, modelling the future, and being honest about what we don't know.

④ The real world M11

What happens once the trial ends and ordinary patients start using the technology.

⑤ How decisions actually get made M12–M13

The agencies, the laws, the deals — and the special cases like rare diseases.

⑥ Doing it for real M14

Tearing apart a manufacturer's submission and writing a recommendation that holds up.

The one idea to carry forward

HTA doesn't ask whether a technology is good. It asks whether it's worth it — given that the money has somewhere else to go.

Everything else in this course is just learning to answer that question well.